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Zoledronic acid results in better health-related quality of life following hip fracture: the HORIZON–Recurrent Fracture Trial

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Abstract

Summary

This study evaluated the benefits of ZOL versus placebo on health-related quality of life (HRQoL) among patients from HORIZON–RFT. At month 24 and end of the study visit, ZOL significantly improved patients’ overall health state compared to placebo as assessed by the EQ-5D VAS.

Introduction

To evaluate the benefits of zoledronic acid (ZOL) versus placebo on health-related quality of life (HRQoL) among patients from The Health Outcomes and Reduced Incidence With Zoledronic Acid Once Yearly Recurrent Fracture Trial (HORIZON–RFT).

Methods

In this randomized, double-blind, placebo-controlled trial, 2,127 patients were randomized to receive annual infusion of ZOL 5 mg (n = 1,065) or placebo (n = 1,062) within 90 days after surgical repair of low-trauma hip fracture. HRQoL was measured using EQ-5D Visual Analogue Scale (VAS) and utility scores (EuroQol instrument) at months 6, 12, 24, 36, and end of the study visit. Analysis of covariance model included baseline EQ-5D value, region, and treatment as explanatory variables.

Results

At baseline, patients (mean age 75 years; 24% men and 76% women) were well matched between treatment groups with mean EQ-5D VAS of 65.82 in ZOL and 65.70 in placebo group. At the end of the study, mean change from baseline in EQ-5D VAS was greater for ZOL vs. placebo in all patients (7.67 ± 0.56 vs. 5.42 ± 0.56), and in subgroups of patients experiencing clinical vertebral fractures (8.86 ± 4.91 vs. −1.69 ± 3.42), non-vertebral fractures (5.03 ± 2.48 vs. −1.07 ± 2.16), and clinical fractures (5.19 ± 2.25 vs. −0.72 ± 1.82) with treatment difference significantly in favor of ZOL. EQ-5D utility scores were comparable for ZOL and placebo groups, but more patients on placebo consistently had extreme difficulty in mobility (1.74% for ZOL vs. 2.13% for placebo; p = 0.6238), self-care (4.92% vs. 6.69%; p = 0.1013), and usual activities (10.28% vs. 12.91%; p = 0.0775).

Conclusion

ZOL significantly improves HRQoL in patients with low-trauma hip fracture.

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Acknowledgments

The authors thank Dr. Nandita Adhikary (Novartis Healthcare Pvt. Ltd.) for her assistance in writing the manuscript and incorporating authors’ comments into subsequent revisions. Dr. Boonen is a senior clinical investigator of the Fund for Scientific Research, Flanders, Belgium (F.W.O.-Vlaanderen) and holder of the Leuven University Chair in Gerontology and Geriatrics. This research was sponsored by Novartis Pharma AG, Basel, Switzerland.

Conflicts of interest

Dr. Adachi reports receiving consulting fees from Amgen, AstraZeneca, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer, Procter & Gamble, Roche, Sanofi-Aventis, and Servier and grant support from Amgen, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer, Procter & Gamble, and Roche.

Dr. Lyles, receiving grant support from Novartis, the Alliance for Better Bone Health (Sanofi-Aventis and Procter & Gamble), and Amgen, consulting fees from Novartis, Procter & Gamble, Merck, Amgen, GTx, GlaxoSmithKline, Eli Lilly, and Bone Medical, and being listed as an inventor on a U.S. patent application (20050272707) covering methods for preventing or reducing secondary fractures after hip fracture and on another provisional patent application for medication kits and formulations for preventing, treating, or reducing secondary fractures after a previous fracture.

Dr. Colón-Emeric, receiving consulting fees from Novartis, Amgen, and research grants from Novartis, Pfizer, and the Alliance for Better Bone Health.

Dr. Boonen, receiving consulting fees and research support from Novartis.

Dr. Pieper, receiving research support from Novartis.

Dr. Mautalen, receiving consulting and advisory board fees from Novartis.

Dr. Hyldstrup, receiving advisory board fees from Novartis, Eli Lilly, and Nycomed, lecture fees from Merck, Eli Lilly, Nycomed, Novartis, Novo Nordisk, and Servier, and grant support from Eli Lilly, Novartis, Pfizer, Nycomed, Roche, and GlaxoSmithKline.

Dr. Recknor, receiving consulting fees from Procter & Gamble, Roche, and Eli Lilly, lecture fees from Procter & Gamble, Eli Lilly, Roche, GlaxoSmithKline, Merck, and Aventis, and grant support from Procter & Gamble.

Dr. Nordsletten, receiving consulting and advisory board fees from Novartis and DePuy, lecture fees from Wyeth, and grant support from Biomet.

Dr. Bucci-Rechtweg and Dr. Su, being employees of and owning stock in Novartis.

Dr. Eriksen (now an employee of Oslo University, Oslo, Norway), being an employee of Novartis during the design and initiation of the study, and receiving advisory board fees from Novartis, Eli Lilly and Amgen.

Dr. Magaziner, receiving consulting fees from Amgen, Merck, Eli Lilly and Novartis, and grant support from Novartis and Merck.

Ms. Moore, no disclosures.

Author information

Authors and Affiliations

  1. St. Joseph’s Healthcare, McMaster University, 501-25 Charlton Ave E., Hamilton, ON, L8N 1Y2, Canada

    J. D. Adachi

  2. Duke University Medical Center and the Geriatrics Research Education and Clinical Center, Veterans Affairs Medical Center, Durham, NC, USA

    K. W. Lyles, C. S. Colón-Emeric, C. F. Pieper & K. A. Moore

  3. University of Leuven, Leuven, Belgium

    S. Boonen

  4. Centro de Osteopatías Médicas, Buenos Aires, Argentina

    C. Mautalen

  5. Hvidovre Hospital, Hvidovre, Denmark

    L. Hyldstrup

  6. United Osteoporosis Centers, Gainesville, GA, USA

    C. Recknor

  7. Ullevål University Hospital, Oslo, Norway

    L. Nordsletten

  8. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

    C. Bucci-Rechtweg & G. Su

  9. Oslo University Hospital Aker, Oslo, Norway

    E. F. Eriksen

  10. University of Maryland, Baltimore, MD, USA

    J. S. Magaziner

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  1. J. D. Adachi
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  14. J. S. Magaziner
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Corresponding author

Correspondence to J. D. Adachi.

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ClinicalTrials.gov registration number

NCT00046254

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Adachi, J.D., Lyles, K.W., Colón-Emeric, C.S. et al. Zoledronic acid results in better health-related quality of life following hip fracture: the HORIZON–Recurrent Fracture Trial. Osteoporos Int 22, 2539–2549 (2011). https://doi.org/10.1007/s00198-010-1514-9

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